Dangerous Ethics Oversight in Purdue Child Nutritional Study: Fordham University’s Dr. Celia Fisher Weighs In

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This past July. an $8.8 million dollar, camp-like nutrition study funded by the National Institutes of Health (NIH) was shut down, resulting in a vast internal investigation at Purdue University, one of the nation’s top research institutions, and raising several issues about research ethics and the role of institutional review boards (IRBs), according to Undark. What went wrong? A video of an adolescent girl showering in a dormitory was posted on social media.

The study, Camp DASH (Dietary Approaches to Stop Hypertension)  was designed to evaluate effects of a low sodium diet on 11- to 15-year-old boys and girls with elevated blood pressure. Purdue University were set to host the children in campus housing for seven weeks in the summer.

The University President Mitch Daniels shut down the study two weeks early after the incident was reported to the police and the county prosecutor began looking into additional allegations of crimes among adolescents in the study. Daniels An investigation led by Purdue University’s Vice President for Ethics and Compliance, Alysa Christmas Rollock was launched soon after. Rollock’s investigation, which Purdue University released November 28, shows over “thirty incidents of threats, violence, or sexual abuse among the study participants, many involving calls to campus police. (Two participants were arrested in the first few days of the study.)” Additionally, Rollock reported several “instances of non-compliance on the part of the study’s principal investigator, or PI, Connie Weaver, that may have contributed to unsafe conditions for the minor participants” as well as “various conflicts of interest inherent in the study’s design.”

Dr. Celia Fisher, Professor of Psychology and Ethics at Fordham University and Director of the University’s Center for Ethics Education explained to Undark that “even if the NIH approved the trial design for the Camp DASH study, they would have relied on the university’s IRB to work out the details for the protection of study participants.”

Fisher, who has been working in the field of research ethics involving vulnerable populations for several decades, and who chaired the creation of the current American Psychological Association Ethics Code, said that she would have expected Purdue University’s IRB approval to be contingent on the “gold standard in counselors.” She continued, after discovering the counselors were primarily undergraduate students, “To have a sleepover camp for young teenagers supervised by 18 to 21-year-olds who do not have an adult supervisor there monitoring…I can’t even.”

Because no federal regulations require that members of IRBs be “scientists or know anything about scientific ethics,” Fisher explained, “not all IRBs are created equal…and vary significantly from institution to institution.” IRBs are typically pulled from university faculty and not paid for their work on the board. She added that because there is a “diverse range of expertise” among IRB members that is not well-suited to every study, “They [IRB members] may try very hard to apply ethical standards, but if they have no understanding of the type of research that’s being conducted, then they may not be able to identify all the risks and benefits of the participation.”

The problem, Fisher concluded, with most university IRB members is that the “lack of expertise and the lack of funding that they get” despite being genuinely interested in the protection of human subjects.”

As a result of the investigation, the study’s remaining three summers of the study are cancelled and “all of the collected data will be thrown out.” The biomedical institutional review board (IRB) of the University stated in late November that future study applications submitted by Weaver will not be reviewed until she submits a “comprehensive remediation plan,” including training and oversight by an outside mentor, according to the article.

Weaver, the study’s PI, released a statement last Tuesday that said, “I am deeply saddened by the instances that caused Camp DASH to end early. As the principal investigator, I accept responsibility for events that occurred at Camp DASH. The safety and security of research participants always comes first.”

Please visit Undark to read the full article, “Purdue University Mounted a Child Nutrition Study. It Went Very, Very Wrong.


Celia B. Fisher, Ph.D. is the Fordham University Marie Ward Doty University Chair in Ethics and Director of the Center for Ethics Education and the HIV and Drug Abuse Prevention Research Ethics Training InstituteFisher’s  Decoding the Ethics Code: A Practical Guide for Psychologist, is now in its fourth edition from Sage Publications.

 

Fordham University’s Dr. Celia Fisher Weighs in on Researchers Using Real Guns in Study with Children in Mic

In a recent study, researchers asked children ages 8 – 12 years old to watch 20-minute clips of PG-rated movies that either included or did not include gun violence. The objective of the study was to test whether children exposed to gun violence in movie clips would 1) handle a real gun longer and 2) pull the trigger more times than children not exposed to the same clip edited to not contain gun violence.

The children were then placed into a university laboratory containing toys, games and a real, 0.38 caliber gun which was disabled and modified to have a sensor counting trigger pulls with the door closed. A research assistant sat in an exterior greeting room if the children had questions. The study found that children who watched the clip containing guns were more likely to use the guns themselves than the children who watched the clip that did not contain guns (median trigger pulls were 2.8 compared to 0.01 and median number of seconds holding the gun were 53.1 compared to 11.1, respectively). Roughly 27% of children informed the assistant about the gun or handed it over and a small number aimed the gun at other children.

Although this study was approved by the scientists’ institutional review board, many ethicists believe the potential harm of the study was “not worth it,” including Dr. Celia Fisher, director of Fordham University’s Center for Ethics Education. “In any kinds of ethics evaluation, we have to balance the risk against the benefit. I think the study’s results are not of great scientific importance because we already know what the result is going to be. We have decades of scientific research showing that kids will imitate aggressive behavior they view on the TV screen,” Fisher told Mic.
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Fordham University’s Dr. Celia Fisher Discusses What the Revised Common Rule Means for Informed Consent in Medical Ethics Advisor

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The Federal Policy for the Protection of Human Subjects, or the Common Rule was revised earlier this year and is set to be effective on January 19th, 2018. The Common Rule was created in 1991 to “better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.” Departments and agencies including, but not limited to, the Department of Homeland Security, the Department of Health and Human Services and the National Science Foundation made these revisions in an effort to “modernize, simplify, and enhance the current system of oversight.”

In this year’s October issue of Medical Ethics Advisor, Dr. Celia Fisher, Director of Fordham University’s Center for Ethics Education and HIV and Drug Abuse Prevention Research Ethics Training Institute, discusses two significant ways the revised Common Rule will change informed consent practices in research, and critical ethical questions to consider about these changes.

According to Dr. Fisher, the first change, stating that investigators are permitted to obtain broad consent from participants for future use of identifiable biospecimens by the original investigator or other investigators, “increases the ability of scientists to combine large data sets to explore important medical questions.” However, she says, “it is unclear whether hacking or the use of the identifiable information…will pose a social or economic risk to participants.” Dr. Fisher continues that it could be additionally problematic if “identifiable data is used to inform policies that promote medical discrimination of already vulnerable groups” without the research participants understanding how their data will be used in the future.

The second revision of the Common Rule that will impact informed consent practices states that investigators are required to give prospective participants a brief summary of “key points” that a reasonable person would want to know to make an informed choice. Dr. Fisher notes that this revision “can be an advantage over the current risk-averse legal language in informed consent materials,” but the revision does not state who will be deciding what the key points are which could be potentially problematic considering participants, investigators and IRB members may have different ideas of what “important information” is.

To read the full article and October’s Issue of Medical Ethics Advisor, please visit their website here. To subscribe to the journal, please visit AHC Media.

Dr. Celia Fisher is the Mary Ward Doty University Chair in Ethics at Fordham University, a professor of Psychology and the director of Fordham University HIV and Drug Abuse Prevention Research Ethics Training Institute. In addition to chairing the 2002 revision of the American Psychological Association’s Ethics Code, Fisher’s Decoding the Ethics Code: A Practical Guide for Psychologists is now in its fourth edition from Sage Publications.  Please visit her webpage for more information about her work, as well as the Fordham University Center for Ethics Education Research page.

NIH’s New Definition of “Children” Finally Gets it Right: A Welcome Change for Children’s Health Equity

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By Celia B. Fisher, Ph.D.

Under current federal research regulations, a “child” is defined as an individual younger than 21 years of age – a policy that has produced inequities in health research for youth younger than 18 years of age.

Beginning January 25th, 2016, that will change: the age of a child will be defined as an individual less than 18 years old. This is a welcome change that can begin to address the urgent need for age- and population-targeted research to avoid the use of treatments tested in young adult populations that may be unsuited for adolescents and children.

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Minimal risk and minimal experience: Can researchers competently navigate OHRP’s new risk categories?

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By: Celia B. Fisher, Ph.D.

The U.S. Department of Health and Human Services has announced proposed revisions to modernize federal regulations governing the protection of research participants’ rights and welfare. The newly proposed regulations have many positive features that will improve the informed consent process through transparency and stricter requirements to protect participant privacy and enhance informed consent.

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Issues of Research Ethics in the Facebook ‘Mood Manipulation’ Study: The Importance of Multiple Perspectives

 

By: Michelle Broaddus, Ph.D.

A new study using Facebook data to study “emotional contagion,” and the ensuing backlash of its publication offers the opportunity to examine several ethical principles in research. One of the pillars of ethically conducted research is balancing the risks to the individual participants against the potential benefits to society or scientific knowledge. While the study’s effects were quite small, the authors argue that “given the massive scale of social networks such as Facebook, even small effects can have large aggregated consequences.” However, participants were not allowed to give informed consent, which constitutes a risk of the research and the major source of the backlash.

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Issues of Research Ethics in the Facebook ‘Mood Manipulation’ Study: The Importance of Multiple Perspectives (full text)

 

By: Michelle Broaddus, Ph.D.

A recent paper published in the Proceedings of the National Academy of Sciences describes a mood manipulation experiment conducted by Facebook scientists during one week in 2012 that suggests evidence of “emotional contagion,” or the spread of positive and negative affect between people. The backlash to this publication has been significant. As two examples, Slate.com published a piece entitled “Facebook’s Unethical Experiment: It intentionally manipulated users’ emotions without their knowledge” and The Atlantic’s piece, “Even the Editor of Facebook’s Mood Study Thought It Was Creepy.”

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